Identity
- Trade Name
- HELMUT ZEPF FDA UDI
- Generic Name
- Dental surgical probe, reusable FDA UDI
- Device Name
- CARVER, WAX FAHNENSTOCK, WAX- & MODELL. CARVER, 17CM STAINLESS STEEL FDA UDI
- Model / Reference
- 28.161.17 FDA UDI
- Description
- CARVER, WAX FAHNENSTOCK, WAX- & MODELL. CARVER, 17CM STAINLESS STEEL FDA UDI
Identifiers
- Catalog Number
- 28.161.17 FDA UDI
- Primary DI / UDI-DI
- EZPF28161170 FDA UDI
- FDA Product Code
- EIK FDA UDI
- GMDN Term
- Dental surgical probe, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental surgical probe, reusable
The HELMUT ZEPF is a dental surgical probe, designed for use in various types of dental surgical interventions. It features a slender, rod-like design with flexible or rigid metallic and/or synthetic polymer materials, making it both reusable and implantable.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Helmut Zepf Medizintechnik GmbH
Sources (1)
- FDA UDI 76dcb7ab-da6d-49b8-a352-d24337fdf41f 35 fields · synced Oct 6, 2026